Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAudioptics Medical Incorporated
About this trial
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults ages 18+
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
OCT - clear
Other interventionOCT imaging and vibrometry
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Hearing loss1 intervention
Trial outcomes
Primary outcomes
1
Vibrometry (Ossicular mobility in mm/s/Pa)
Optical Coherenece Tomography vibrometry measures of ossicular mobility for the umbo and incus in mm/s/Pa for 6 frequencies of 500, 750, 1000, 1500, 2000 and 3000 Hz
Time frame
2 years2
Standard audiometry--threshold measurement in dBHL
Standard pure tone and bone conduction audiometry--measurement of acoustic thresholds for air and bone conductive stimuli at 250, 500, 1000, 2000, 3000 , 4000, 6000 and 8000 Hz
Time frame
2 years3
Standard tympanometry--measurement of acoustic immittance in daPa
Standard tympanometric testing of ear canal volume and middle ear immittance
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Audioptics Medical Incorporated
Lead sponsor
Nova Scotia Health Authority
Collaborator
Dalhousie University
Collaborator
Source ClinicalTrials.gov
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